| Primary Device ID | 00365702702431 |
| NIH Device Record Key | 3fbae879-a1bd-4b9e-aaa3-249493911953 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accu-Chel Guide |
| Version Model Number | 08387052001 |
| Company DUNS | 141608724 |
| Company Name | Roche Diagnostics Operations, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00365702702431 [Primary] |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-09-30 |
| Device Publish Date | 2019-02-28 |
| 00365702703209 - ACCU-CHEK GUIDE | 2025-03-28 VIAL LBLD 30CT STRIP ACCU-CHEK GUIDE |
| 10365702703213 - ACCU-CHEK GUIDE | 2025-03-28 ACCU-CHEK GUIDE CASH VALUE KIT |
| 10365702703237 - ACCU-CHEK GUIDE | 2025-03-28 ACCU-CHEK GUIDE CASH US 30CT STRIP |
| 10365702703251 - ACCU-CHECK GUIDE | 2025-03-28 ACCU-CHEK GUIDE CASH US 60CT STRIP |
| 00365702702417 - ACCU-CHEK GUIDE LINK | 2023-09-29 ACCU-CHEK GUIDE LINK MG/DL 118 |
| 10365702702889 - ACCU-CHEK GUIDE LINK | 2023-09-29 ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US |
| 10365702702476 - ACCU-CHEK GUIDE LINK | 2023-09-14 Accu-Chek Guide Link SC mg/dL |
| 10365702702537 - ACCU-CHEK GUIDE LINK | 2023-09-14 Accu-Chek Guide Link MO Replacement US |